Msg ID:
2700859 |
Pfizer +3/-14
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Author:Truth
8/25/2021 9:14:50 PM
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Pfizer "vaccine" is not approved. Read the release. FDA LUA It is all lawyer speak. Page 11 and 12
Conditions Related to Printed Matter, Advertising, and Promotion
X. All descriptive printed matter, advertising, and promotional material, relating to the use of the Pfizer-BioNTech COVID‐19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.
Y. All descriptive printed matter, advertising ,and promotional material relating to the use of the Pfizer-BioNTech COVID‐19 Vaccine clearly and conspicuously shall state that:
Page 12 – Pfizer Inc.
• This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
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Msg ID:
2700862 |
Pfizer +6/-0
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Author:When you see truth or fact in a post
8/25/2021 9:23:47 PM
Reply to: 2700859
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it's anything but, 100% of the time |
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Msg ID:
2700864 |
Pfizer +0/-1
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Author:Fire Pilot
8/25/2021 9:27:08 PM
Reply to: 2700862
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Read for yourself. The facts are before you but you are too lazy to read. |
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Msg ID:
2700870 |
Pfizer +3/-3
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Author:Slick
8/25/2021 9:51:40 PM
Reply to: 2700864
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Hate to be a downer but the letter posted isn't legit. Go to the FDA website and read, what I guess is bad news for the anti-vaxers.
It's fully approved for 16 and over and approved for 12-15 as an emergency approval.
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Msg ID:
2700874 |
Pfizer +2/-1
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Author:Fire Pilot
8/25/2021 10:23:40 PM
Reply to: 2700870
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It is 100% "legit" if you look for it. The media is lying.
I took that straight out of the Letter Of Authorization dated August 23, 2021. The letter is contained on the FDA's Website. Then scroll to "Letter Of Authorization dated August 23, 2021".
Read it, page 2- "On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older."
page 11 and 12
Conditions Related to Printed Matter, Advertising, and Promotion
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All descriptive printed matter, advertising, and promotional material, relating to the use of the Pfizer-BioNTech COVID‐19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.
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All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‐19 Vaccine clearly and conspicuously shall state that:
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This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
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The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
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Msg ID:
2700879 |
Pfizer +1/-1
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Author:Fire Pilot
8/25/2021 10:57:58 PM
Reply to: 2700874
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As pilots needing medicals it is very important that we learn to understand this stuff.
The FDA approved the Biologics License Application (BLA) ONLY, not the vaccine and reissued the Emergency use Authorization and expanded the EUA to 12 to 16 y/o's. Here is that document. https://www.fda.gov/media/151710/download
The FDA then goes on to describe what the company needed to get full approval and gave a timeline to finish in 2027.
--------------------------------------------------------------------------------------------------------------------------
Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies:
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StudyC4591009,entitled“ANon-InterventionalPost-ApprovalSafetyStudyof the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 31, 2021 Monitoring Report Submission: October 31, 2022 Interim Report Submission: October 31, 2023 Study Completion: June 30, 2025
Final Report Submission: October 31, 2025
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StudyC4591021,entitled“PostConditionalApprovalActiveSurveillanceStudy Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus
Page 7 – STN BL 125742/0 – Elisa Harkins
Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 11, 2021 Progress Report Submission: September 30, 2021 Interim Report 1 Submission: March 31, 2022 Interim Report 2 Submission: September 30, 2022 Interim Report 3 Submission: March 31, 2023 Interim Report 4 Submission: September 30, 2023 Interim Report 5 Submission: March 31, 2024 Study Completion: March 31, 2024 Final Report Submission: September 30, 2024
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StudyC4591021substudytodescribethenaturalhistoryofmyocarditisand pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: January 31, 2022 Study Completion: March 31, 2024 Final Report Submission: September 30, 2024
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StudyC4591036,aprospectivecohortstudywithatleast5yearsoffollow-upfor potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network).
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021 Study Completion: December 31, 2026
Page 8 – STN BL 125742/0 – Elisa Harkins
Final Report Submission: May 31, 2027
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StudyC4591007substudytoprospectivelyassesstheincidenceofsubclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this assessment according to the following schedule:
Final Protocol Submission: September 30, 2021 Study Completion: November 30, 2023 Final Report Submission: May 31, 2024
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StudyC4591031substudytoprospectivelyassesstheincidenceofsubclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021 Study Completion: June 30, 2022 Final Report Submission: December 31, 2022
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Msg ID:
2700890 |
And the earth is flat +11/-4
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Author:Thank you for you inaccurate information
8/26/2021 1:12:58 AM
Reply to: 2700859
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Why do people like yourself persists on trying to harm others?
Facts:
1. The Pfizer "VACCINE" is safe and prevents nearly 100% of people from getting serious illness or death from covid
2. It dramatically lowers the viral load if someone does get Covid
3. Hundreds of millions of doses have been adminstered
4. It has gotten FULL approval by the FDA
The FDA calls it a "Vaccine" and indicates on its public website that it HAS BEEN APPROVED
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Msg ID:
2700891 |
You don't understand how to read technical stuff +1/-2
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Author:But it's not your fault
8/26/2021 1:15:07 AM
Reply to: 2700859
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You don't understand what you're reading, so you post false stuff.
Someone in the thread pointed out what it means and who it is approved for.
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Msg ID:
2700904 |
You don't understand how to read technical stuff +0/-0
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Author:vax
8/26/2021 8:11:15 AM
Reply to: 2700891
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https://news.yahoo.com/u-data-show-rising-breakthrough-181525317.html |
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Msg ID:
2700906 |
And it's still highly effective +7/-3
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Author:--
8/26/2021 8:15:34 AM
Reply to: 2700904
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What part of that are you missing?
98% of all people in the ICUs are unvaccinted
Yes, there will be some "breakthrough" infections, but the following still holds true
1. Getting the vaccine nearly guarantees you will not wind up in the hospital
2. Getting the vaccine nearly guarantees you won't have to go to the ICU
3. Getting the vaccine nearly guarantees you won't die of Covid
4. Getting the vaccine greatly reduces your chance of spreading it to someone else
5. If You still do get covid, your symptoms and duration will be far far less
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Msg ID:
2700908 |
And it's still highly effective +1/-1
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Author:vax
8/26/2021 8:25:13 AM
Reply to: 2700906
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(This August 24 story corrects figures in 5th paragraph to read: 0.5% admitted to intensive care, from 0.05%; and to 0.2% placed on a ventilator from 0.25%)
By Julie Steenhuysen
CHICAGO (Reuters) - Some 25% of SARS-CoV-2 infections among Los Angeles County residents occurred in fully vaccinated residents from May through July 25, a period that includes the impact of the highly transmissible Delta variant, U.S. officials reported on Tuesday.
The data, published in the U.S. Centers for Disease Control and Prevention's weekly report on death and disease, shows an increase in so-called "breakthrough" infections among fully vaccinated individuals. I am just a mechanic, but 25 from 100 ain't 98
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Msg ID:
2700897 |
Pfizer +2/-0
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Author:FDA Approval was expected.
8/26/2021 3:55:14 AM
Reply to: 2700859
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Did anyone think that the FDA would not approve the Vaccine after a 100 million Americans have taken the shot? The impact and ramifications of turning down any of the current vaccines would be huge. Keep in mind that the FDA approves many drugs that do as much harm as good for health issues. Have you ever seen the commercials for drugs these days? The side effects are worse then the health issue. So no, The FDA presents no confidence for me and hasn't for years.
Somehow the anti-vaxers always get hammered as Trump or Republicans. Not true at all. The highest percent of those not vaccinated are Latino and Black Americans. My family has all been vaccinated and are republicans. Most are just wary or have no confidence in the CDC or government.
I have no issue at all with the Vaccine. However it is no more then a Band-Aid for the virus. You will have less severe illness from Covid, but some still die from the virus with the vaccine. Having the vaccine protects you ZERO from catching Covid, or being a carrier and giving it to others. Though the government is screaming for 100 percent vaccinated, it will do nothing to bring back normalcy into society. In the same breath the government is saying though vaccinated you still need to wear a mask. Really? So besides keeping some of us from getting severely ill from Covid, the vaccines have NOTHING to move us forward.
I read an article yesterday from the CEO of Pfizer stating there will be a variant that the vaccine will not protect or lower the effects of the illness. They can produce with another shot within 45 days. The result is hospital beds filling up again, even if your vaccinated. So no cure, just continued shots. A cure doesn't make money. Welcome to the 21st Century.
Here is a copy/paste of the Criteria issuance of authorization:
B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and
C. There is no adequate, approved, and available9 alternative to the emergency of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19. 10
As stated above, the approval is Still under emergency use. This was dated Aug 12, 2021.
Of course I could find nothing about the Known and Potential risks in the entire approval document. The vaccine is not cut and dry in its approval. Not surprising at all. My hope is in the future they find a true vaccine as those before these, one shot, maybe a second booster, and Covid is done. Currently we have nothing more then a flu shot that may or may not work....until the next variant. |
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Msg ID:
2700905 |
Pfizer +1/-0
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Author:Anonymous
8/26/2021 8:13:35 AM
Reply to: 2700859
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U.S. data show rising 'breakthrough' infections among fully vaccinated |
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Msg ID:
2700909 |
The KillShot you got has not been approved +2/-1
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Author:and is going to kill you.
8/26/2021 8:30:35 AM
Reply to: 2700859
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Z |
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Msg ID:
2700968 |
The KillShot you got has not been approved +2/-1
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Author:It is killing people
8/26/2021 2:09:39 PM
Reply to: 2700910
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https://www.openvaers.com/covid-data |
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Msg ID:
2700973 |
Pfizer +6/-2
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Author:Really
8/26/2021 2:48:18 PM
Reply to: 2700859
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I don't know what letter some folks are reading but the letter on the web site, if read in context and it's entirety, clearly stes the the vaccine is fully approved for 16 year olds and above, cleared for use 12-15 years as an emergency clerance, It also stat that clearly most of the labels will state "emergrncy authorization" and it is OK to use the as proscribed in the letter. |
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Msg ID:
2701076 |
Pfizer +2/-1
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Author:Hmmmm...
8/27/2021 10:24:46 AM
Reply to: 2700973
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Approved in < a year!?!?! Sure go ahead sheeple!!! |
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Msg ID:
2700992 |
Pfizer +2/-0
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Author:Yep
8/26/2021 5:57:18 PM
Reply to: 2700984
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With their G650's @ least 3 of them & 4 AW139's in the Taj Mahal hangar @ KTTN they need MORE $$ for thier coffers!!! |
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Msg ID:
2701449 |
Pfizer +0/-0
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Author:The mind
8/30/2021 1:40:50 PM
Reply to: 2700859
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boggles. There are going to be so many lawsuits over employers demanding employees get vaccinated as a condition of employment if the employee can't find the Pfizer vaccine that is approved by FDA vice the one that is only approved for EUA, namely Pfizer-BioNtech, which it is alleged has already produced 600,000 adverse reactions which puts it in W H A T category?
Doesn't appear to be lawyer jargon, just people not paying strict attention, particularly employers. |
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Msg ID:
2701588 |
So sad... (NT) +0/-0
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Author:DJT
8/31/2021 5:17:43 PM
Reply to: 2700859
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